Alvespimycin Hydrochloride in Treating Patients With Metastatic or Unresectable Solid Tumors (NCT00089362) | Clinical Trial Compass
CompletedPhase 1
Alvespimycin Hydrochloride in Treating Patients With Metastatic or Unresectable Solid Tumors
United States30 participantsStarted 2004-07
Plain-language summary
This phase I trial is studying the side effects and best dose of alvespimycin hydrochloride in treating patients with metastatic or unresectable solid tumors. Drugs used in chemotherapy, such as alvespimycin hydrochloride, work in different ways to stop tumor cells from dividing so they stop growing or die.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically confirmed solid tumor, including, but not limited to, the following:
* Prostate
* Breast
* Ovary
* Colon
* Kidney
* Head and neck
* Stomach
* Melanoma
* Metastatic or unresectable disease
* No standard curative or palliative therapy exists or is no longer effective
* Progressive disease as indicated by the following:
* Non-prostate cancer
* New lesions or increase in pre-existing lesions on bone scintigraphy, CT scan, MRI, or by physical examination
* No increase in biochemical markers (e.g., carcinoembryonic antigen or CA-15-3) or symptoms as sole evidence of disease progression
* Prostate cancer
* Must have castrate metastatic disease (i.e., disease progression after castration or treatment with a gonadotropin-releasing hormone \[GnRH\] analog)
* Patients who have not undergone surgical orchiectomy must continue with medical therapy (i.e., GnRH analogs) to maintain castrate levels of serum testosterone \< 50 ng/dL
* Patients who received an antiandrogen as part of first-line hormonal therapy must show disease progression after discontinuing treatment
* Progressive metastatic disease on imaging studies (e.g., bone scan, CT scan, or MRI) OR metastatic disease and a rising prostate-specific antigen (PSA) allowed
* Biochemical progression is defined as a minimum of 3 rising PSA values from baseline obtained at least 1 week apart OR 2 rising PSA values obtained more than 1 month apa…
What they're measuring
1
MTD, defined as the dose level where the observed DLT incidence in no more than one out of six patients treated at a particular dose level